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Anti-viral

Preemptive Mavyret Therapy for Hepatitis C in Organ Transplant Recipients

Phase 4
Recruiting
Led By Bashar A Aqel
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing if a combo of 2 drugs can prevent HCV infection from a positive donor to a negative recipient during organ transplant.

Who is the study for?
This trial is for kidney, heart, lung, or pancreas transplant patients without chronic hepatitis C. Participants must be willing to accept a graft from a donor with hepatitis C and understand the risks of acquiring HCV infection. Those with chronic liver disease, pregnant women, or individuals with HIV or chronic hepatitis B cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness of Mavyret in preventing the transmission of Hepatitis C from an infected donor to a recipient who does not have Hepatitis C during organ transplantation.See study design
What are the potential side effects?
Mavyret may cause side effects such as headache, fatigue, nausea and insomnia. It can also lead to temporary increases in certain liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft and patient survival
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs

Side effects data

From 2020 Phase 4 trial • 10 Patients • NCT02946034
30%
fatigue
10%
Hypertensive emergency
10%
anemia
10%
Cryoglobulinemic glomerulonephritis
10%
Heart block
10%
muscle pain in leg
10%
cryoglobulinemia
10%
slow ventricular response
10%
high potassium
10%
Seizure
10%
Fall / loss of consciousness
10%
Abdominal pain
10%
Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Viekira Pak ± Ribavirin or Mavyret

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1: Pre-emptive Treatment ArmExperimental Treatment1 Intervention
Single arm study were all recipients of HCV viremic organs will receive combination therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavyret
2018
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,766,950 Total Patients Enrolled
6 Trials studying Hepatitis C
2,385 Patients Enrolled for Hepatitis C
Bashar A AqelPrincipal InvestigatorMayo Clinic

Media Library

Mavyret (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT04508907 — Phase 4
Hepatitis C Research Study Groups: Arm 1: Pre-emptive Treatment Arm
Hepatitis C Clinical Trial 2023: Mavyret Highlights & Side Effects. Trial Name: NCT04508907 — Phase 4
Mavyret (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04508907 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
Bashar Aqel 2020. "A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04508907.
All > Autoimmune Hepatitis > Hepatitis C
~31 spots leftby Dec 2024
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